Second Phase of the Pilot Study for Obtaining Mature Oocytes by in Vitro Maturation in Oocyte-donor Women

Infertility, Female Clinical Trial

— MIVODON-II  

Official title:

Second Phase of the Pilot Study for Obtaining Mature Oocytes by in Vitro Maturation in Oocyte-donor Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06103383
• Other study ID #: 2109-VLC-083-EB
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: LAURA CARACENA, Msr
• Phone: 034 963050900
• Email: laura.caracena[@]ivirma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In vitro maturation (IVM) is a technique for obtaining potentially fertilizable oocytes from immature oocytes. An oocyte must be mature both nuclearly and cytoplasmically in order to be competent in the reproductive process. Nuclear maturation involves an oocyte in metaphase II stage and is easily evaluated for its morphology. However, cytoplasmic maturation can only be evaluated by in vitro fertilization of that oocyte. A mature nuclear and cytoplasmic oocyte is the one capable of producing a viable embryo. This study aims to optimize the in vitro maturation (IVM) technique to achieve nuclear mature oocytes, i.e., to mature the oocytes up to the metaphase II stage. In addition, an artificial oocyte activation (AOA) will be carried out to check the cytoplasmic maturation of the oocytes, avoiding the generation of potentially viable embryos.

This study corresponds to a second phase of the pilot study for the development of this technique in our IVF laboratory. We will use all we have learned in the first phase, as well as the experience acquired, to advance in the optimization of this protocol.

The correct functioning of this IVM technique would mean a reduction in the costs of ovarian stimulation treatments, as lower doses and shorter stimulation times are required, which implies lower risks for women derived from the medication and less stress for them.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

-Inclusion criteria:

Women between 18-35 years old who have belonged to the egg donation program. Donors who agree to participate in the study after informing and signing the Informed Consent.

Documented previous good response to ovarian stimulation (at least 10 total oocytes and/or 8 MII).

Donors with at least one previous donation cycle, in which all oocytes obtained were freshly fertilized.

Donors who have already done all their donation cycles allowed by law. No personal or family history of interest.

From the medical point of view:

Body mass index between 18-25 kg/m2. Normal uterus and ovaries, without organic pathology. No polycystic ovaries Antral follicle count (AFC) >12 in the sum of the two ovaries on day 2-3 of the menstrual cycle. Normal karyotype Negative screening for infectious diseases (Hepatitis B virus, Hepatitis C virus, Human Immunodeficiency Virus and Syphilis). General analysis with hemogram, hemostasis and biochemistry with parameters within normality.

-Exclusion criteria:

Any systemic or metabolic disorder that contraindicates the use of gonadotropins.

Any medical condition that implies non-inclusion in the oocyte donation program.

Taking hormonal contraceptives within the last 3 months.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Oocyte Maturation

Intervention

Drug:
• Controlled ovarian stimuation
3 days stimullation protocol using hMG-HP

Procedure:
• Oocyte pick up
Surgical oocyte pick up without triggering
• Oocyte in vitro maturation
In vitro maturation procedure
• Oocyte in vitro activation
In vitro oocyte activation procedure

Locations

Country	Name	City	State
Spain	Ivi Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oocyte in-vitro maturation	To evaluate the rate of potentially competent oocytes (after the in vitro maturation).	1 YEAR
Primary	Oocyte activation	To evaluate the rate of potentially competent oocytes after oocyte activation process.	1 YEAR
Secondary	Oocyte recovery rate	To evaluate Oocyte recovery rate per punctured follicle	1 year
Secondary	In vitro nuclear maturation rate	To evaluate In vitro nuclear maturation rate per punctured follicle	1 year
Secondary	Artificial oocyte activation rate.	To evaluateArtificial oocyte activation rate. per punctured follicle	1 year